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510(k) K202846

TERA HARZ by Graphy, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2021
Date Received
September 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

Other clearances by Graphy, Inc.

  • K253681 — TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HA (November 21, 2025)
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  • K233502 — TERA HARZ II (November 1, 2023)
  • K223355 — Tera Harz Clear (November 3, 2022)
  • K222414 — TERA HARZ DENTURE (August 11, 2022)

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